{"id":"dtap-hb-prp-t-combined-vaccine","safety":{"commonSideEffects":[{"rate":"10–50","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"10–30","effect":"Fever"},{"rate":"10–30","effect":"Irritability or fussiness"},{"rate":"5–20","effect":"Drowsiness"},{"rate":"5–15","effect":"Loss of appetite"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DTaP-HB-PRP~T is a pentavalent vaccine combining five separate immunizations into one injection. It contains inactivated diphtheria and tetanus toxoids, acellular pertussis antigens, hepatitis B surface antigen (produced via recombinant DNA), and polyribosylribitol phosphate (PRP) from Hib conjugated to tetanus toxoid. Upon administration, these antigens trigger both humoral (antibody) and cell-mediated immune responses, conferring protection against these five serious bacterial and viral diseases.","oneSentence":"This combined vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (Hib) by presenting inactivated toxins and bacterial antigens.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:09.141Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"nctId":"NCT06793826","phase":"","title":"Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2025-01-17","conditions":"Hepatitis B, Haemophilus Influenzae Type b Immunisation","enrollment":713},{"nctId":"NCT05794230","phase":"PHASE3","title":"Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2023-03-27","conditions":"Meningococcal Immunisation, Healthy Volunteers","enrollment":1528},{"nctId":"NCT03630705","phase":"PHASE3","title":"Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2018-10-17","conditions":"Healthy Volunteers (Meningococcal Infection)","enrollment":525},{"nctId":"NCT02817451","phase":"PHASE3","title":"DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2016-07-14","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":53},{"nctId":"NCT02428491","phase":"PHASE3","title":"Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2015-04-20","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":354},{"nctId":"NCT00514709","phase":"PHASE3","title":"Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2007-09","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":1843},{"nctId":"NCT00619502","phase":"PHASE3","title":"Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2007-12","conditions":"Diphtheria, Polio, Pertussis","enrollment":254},{"nctId":"NCT00831753","phase":"PHASE3","title":"Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2008-05","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":263},{"nctId":"NCT01948193","phase":"PHASE3","title":"Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2014-02","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":177},{"nctId":"NCT00315055","phase":"PHASE3","title":"Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-07","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":310},{"nctId":"NCT00362336","phase":"PHASE3","title":"Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-08","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":622},{"nctId":"NCT00313911","phase":"PHASE3","title":"Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-07","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":2133},{"nctId":"NCT00401531","phase":"PHASE3","title":"Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-10","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":412},{"nctId":"NCT00831311","phase":"PHASE2","title":"Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2004-10","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":624},{"nctId":"NCT00343889","phase":"PHASE3","title":"Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-08","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":379},{"nctId":"NCT00534833","phase":"PHASE3","title":"Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2007-09","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":362},{"nctId":"NCT00348881","phase":"PHASE3","title":"Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-06","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":2133},{"nctId":"NCT00303316","phase":"PHASE3","title":"Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-02","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":458}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"DTaP-HB PRP~T Combined Vaccine","genericName":"DTaP-HB PRP~T Combined Vaccine","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combined vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (Hib) by presenting inactivated toxins and bacterial antigens. Used for Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b in infants and children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}